Guidance for Industry on Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Major, Minor, and Telephone Amendments to Abbreviated New Drug Applications." This guidance is a second revision of the guidance entitled "Major, Minor, FAX, and Telephone Amendments to Original Abbreviated New Drug Applications." FDA's Office of Generic Drugs (OGD) determined that further revision of the policy regarding determination of major, minor, and telephone amendments was necessary to help streamline the review of abbreviated new drug applications (ANDAs).